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Hecker & Associates, LLC

Product Development Experience
Regulatory Strategy
US Agent
Seminars and Events

307 North Garfield St.
Arlington, VA 22201-1261



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Drug/Biologic Development Experience

Picture of Sandra J Hecker
Sandy’s interest in drug development began in 1988 when she was appointed to an Institutional Review Board (IRB) for the National Institute of Allergy and Infectious Diseases (NIAID), at NIH. Along with the other IRB members she reviewed a large number of clinical trial protocols and investigator brochures for scientific merit and patient safety. In 1990 when she joined Genentech to create the medical writing/submissions department, her experience reading those documents was put to good use creating submission templates. After Genentech, she moved back east and back to NIAID, where she was Scientific Assistant to the Director, but she missed the business side of promising scientific research, as demonstrated by Genentech’s unofficial motto: “Do it better, faster, cheaper!” So she went back to industry, this time into the Contract Research Organization (CRO) world, managing a succession of regulatory submissions writing groups, first in Medical Affairs, and then in Regulatory because she wanted to work on entire applications, and be part of identifying and implementing a project’s big picture strategy to achieve client goals.

At Genentech she oversaw contract workers supporting her department’s submissions, and at CROs, she worked as a contractor for sponsors. Sandy cares as much about the success of the client’s project, as the client does, as a reliable, always available team member. Her approach has led multiple clients to transfer other work to her too, because she is “so quickly responsive.”

Sandy’s experience coaching teams and filing strategic submissions as efficiently as possible was put to use helping clients when she started her own business in 2001. From her experience managing contractors, Sandy understands that the contractor must be reliable, accessible, anticipate and prevent any wrinkles in the drug development process, and keep executives advised about options for addressing issues that may arise, so they can be dealt with before they become problems. Since 1990, Sandy has worked on 35 clinical trial applications filed to FDA and/or Health Canada. Of these, only one was put on Clinical Hold by FDA and Health Canada, because a clinical trial run by a different sponsor treating similar patients with a related product, had safety problems. Working with FDA and Health Canada, Sandy and her client team convinced the US and Canadian agencies to allow the trial to proceed and the study was successfully completed.

Also since 1990, Sandy has worked on 22 marketing applications, filed to FDA, Health Canada, and various agencies in Europe. Working on marketing applications, Sandy likes to integrate herself into the sponsor team, and has typically been responsible for a particular area, such as managing the review and finalization of 75 clinical study reports by a global team based in Japan, the US, and Europe, or shepherding a problem safety summary through review and finalization. Her marketing application support includes responding to questions from FDA, Health Canada, or EMA, sometimes on a very tight timeline. Some of her proudest accomplishments were helping get on the market in multiple regions Genentech’s Pulmozyme for cystic fibrosis, Pfizer’s Celebrex for arthritis, and Otsuka/BMS’s Abilify for schizophrenia. Meeting or hearing about patients whose lives were saved or improved by these products, makes the hard work and long hours worthwhile.

The majority of Sandy’s regulatory submissions have been for CNS, oncology, and cardiovascular projects. Her work as a contractor since 1996 enables her to quickly assess the status of a project she’s asked to facilitate, and get up to speed on its scientific and regulatory issues rapidly.

Her clients have included small or novice companies in the US, Europe, Canada, New Zealand, and Asia, academic groups in the US, venture capitalists, and biotech/pharma companies that needed help with a particular project where she became part of or led a global team. Sandy particularly loves working cross-culturally and as US Agent to FDA for foreign companies without a presence in the US.

Because drug development regulations, guidelines, and best practices are constantly changing, Sandy is active in management of the Drug Information Association (DIA), her main professional society, where she is a member of management committees focused on regulatory submission strategy and global submission best practices. She has also been on the Program Committee or a speaker or session chair at numerous DIA and Regulatory Affairs Professionals Society (RAPS) meetings since 1999. Her topics have included Global Submission Best Practices, US Agent Best Practices, Effective Submission Content/Management, Successful Global Team Project Management, and Career Development topics for regulatory staff, medical writers, and project managers.

Through her former project teams and her professional societies, Sandy maintains a large network of individuals with extensive expertise—from subspecialties in chemistry and manufacturing, to nonclinical regulatory knowledge supporting various product types and clinical pharmacology, to medical experts on a wide range of indications. She confidently recommends these individuals to her clients because she has worked successfully with them on prior projects and knows them to be knowledgeable, reliable contractors.

Sandy regards drug development as like a steeplechase on horseback—“you never know what you’ll have to jump next—how far or how wide,” but with her extensive experience, an entrepreneurial problem-solving outlook, and a determination that her clients will succeed if at all possible, Sandy loves helping client teams learn and navigate the complex drug development pathways, so as to get ever better products on the US market, as time- and cost-effectively as possible.